CTRI/2013/04/003527已完成4 期
A Prospective, Open Label study to evaluate the Effect of standardized wheat flakesbreakfast provided within an energy restricted diet plan along with a controlledphysical activity regimen, on weight loss among overweight subjects. - Nil
Spectrum Clinical Research PvtLtd0 个研究点目标入组 70 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. BMI is greater than or equal to 23 and less than or equal to 30 at study entry
- •2. Not Allergic to milk or wheat
- •3. Not enrolled in the gym
- •4. For females only: without childbearing potential or negative HCG hormone blood test
- •and use of an appropriate form of contraception
- •5. Willing to take the wheat flakes as prescribed and sign an inform consent document
- •for participation in the study
排除标准
- •1. Illness e.g. diabetes, hypertension or cholesterol problems etc. / thyroid problems
- •2. Participants on Medication/ special diets for weight loss
- •3. Gastrointestinal disorders that might cause complications or influence motility or satiety.
- •4. Fasting serum glucose > 126 mg/dL.
- •5. Conditions for which weight loss may not be appropriate (e.g., HIV/AIDS, cancer)
- •6. Use of medications that might affect weight or food absorption (e.g., diuretics,glucocorticoids, laxatives).
- •7. Alcohol consumption more than 20ml /day.
- •8. Currently smokes cigarettes due to the effects of nicotine on appetite
- •9. Pregnant and lactating women
- •10. Athletes or patients who do exercises every day
- •11. Patients suffering from Mal-Absorption Syndrome
- •12. Patients who are unlikely to comply with Protocol requirements e.g. uncooperative
- •attitude, patients who are frequent travelers, inability to return for follow up visits
- •13. Patient participating in any other clinical trial
研究者
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